As of November 13, 2015—54 facilities have been registered as Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Nine of these registered facilities have not yet been inspected by USFDA. The balance of the registered facilities have been inspected by USFDA with 100% of these facilities receiving a Form 483 on conclusion of the initial inspection.

Note: A FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Three of the originally inspected facilities have received a second FDA inspection. Each of these facilities (100% of those inspected) received a Form 483 on conclusion of the repeat inspection.

The track record for FDA inspection of 503B Outsourcing Facilities is very poor with 100% of the inspected facilities receiving Form 483’s on conclusion of the initial and even second inspection. Clearly something is amiss as this should not be the case for the following reasons:

  • The FDA inspection process is available from the FDA website.
  • Compliance Policy Guides which are used during the FDA Inspection by the FDA Inspector are available for drug and sterile drug operations.
  • FDA lists every Form 483 issued to every registrant – this is a gold mine of the types of issues that FDA has previously identified in the exact same type of facilities – Learn from the mistakes of others.

If you have registered with FDA and are in the queue for inspection—you need to be proactive in preparation, find a consultant that will help you know what to expect and are prepared for a successful inspection. Performance Validation recently completed a pre-registration consultation with a prospective 503B facility focusing on understanding cGMPs, communicating common findings, and sharing the FDA inspection methodology.

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